Fecal incontinence is the impaired ability to control bowel movements. Many patients with fecal incontinence have little or no control over their bowel movements, causing distress and embarrassment and limiting the social activity of the patient. In some patients, particularly older ones, fecal incontinence can cause additional problems such as bed sores, which may lead to gangrene, which may, in turn, result in death. Fecal incontinence is a condition that requires substantial time and labor on part of many health care personnel in hospitals and nursing homes, as well as on the part of the family members of the suffering patient.
Several approaches have been used in order to treat, or at least care for, fecal incontinence. The most simple and common method, which does not actually treat the fecal incontinence but which rather treats the consequences thereof, is the use of an absorbent, such as a diaper. However, diapers are not comfortable to wear, cannot be conveniently used in public, and further, may cause bed-sores, mainly in older patients. Other treatments include invasive surgery, which is considered to be a relatively dangerous procedure that cannot be used on all patients, especially if they are suffering from additional conditions or are at an age where invasive surgery may be life threatening.
U.S. Pat. No. 4,813,422 (Fisher et al.) discloses a bowel probe and method for controlling bowel incontinence. The disclosed probe comprises a catheter with an infrared sensor tip, used for sensing fecal mass in the rectum, and a cuff that is inflated to prevent passage of the rectal mass.
However, although previously disclosed devices and methods have, to an extent, been successful in managing incontinence, they are not always reliable or conveniently used. Further, many of the disclosed methods, such as the use of tampon-like devices, create lateral pressure on the rectal wall, which may be both dangerous and painful. Additionally, the anal canal includes two regions, separated by what is known by the dentate line. Generally, the region below the dentate line is highly innervated and, therefore, the presence of a device in that area is painful. The peristaltic movements of the intestines tend to push out anything found within the intestines, and, therefore, they are pushed out of the patient's body, thus being ineffective.
Therefore, there is a need in the art for a non-invasive, reliable device and method for treating fecal incontinence without causing pain or damage to the patient.